This invention relates primarily to the treatment of lymphedema, and the use of various instrumentation that can effectively lessen the painful and deleterious aspects of such disease as manifested in the body.
The occurrence of pressure of pressure ulcers has recently gained prominence as national health care issues. Such ulcers remain a major cause of morbidity and mortality. The National Pressure Ulcer Advisory Panel (NPUAP) defines a pressure ulcer as a area of unrelieved pressure over a defined area, usually a boney prominence, resulting in Ischemia, cell death, and tissue neurosis. The major sites for such ulcers include the ischium (28%), sacrum (17-27%), the femoral trcanter (12-19%), and the (9-18%). The incidence in hospitalized patients ranges from 3.5% to 69% depending on the risk factors and acute and chronic institutions. Surprisingly, the incidence is hirer in acute care institutions than in chronic long term care facilities. Operations for non elective orthopedic procedures, e.g. hip replacement and long bone fractures, have an incidence of 66% for those procedures. Increased time on the operating table also increases the risk of ulcers, with one study reporting an increased risk of 33% for every minute on the operating table for over four hours. In the nursing home environment, the prevalence of such ulcers ranges between 2.6-24%. In acute care facilities, it is 25%.
Pressure ulcers are one of the most costly diseases to treat. A study for vendors of medicare and Medicaid services, a conducted, and as reported, says that over 257,000 cases of preventable pressure ulcers occurred in the fiscal year of 2007. They also reported the average cost for treatment of one of these cases is over $43,000. That's over 11 billion dollars in preventable health care cost. Just recently, medicare has changed the payout rules at it will no longer pay for hospitable mistakes, one of which is hospital acquired pressure ulcers.
The accepted theorem for causing pressure ulcers is a sustained pressure on a surface of subcutaneous tissue, the pressure being in a range of 32 to 40 mn of hg for two hours. This is sufficient to close the capillary bed blood flow. A recent study demonstrated that pockets of subcutaneous edema when a person was in a prone position on a hard surface for one hour. An area subject to prolong pressure by a person lying on a hard surface, such as an operating table, applies pressure to the skin and subcutaneous tissues and place on the skin covering the coccyx tail bone for one hour. Post pressure was sonigraphically tested and images exhibited pockets of deep edema or lakes. These lakes of edema fluid (extra cellular fluid) caused a decrease of blood flow, both arterial and venous, and has contributed to the pathogenic development of pressure ulcers. Considering these findings of lakes of sub dermal extra cellular fluid as possible causes of pressure ulcers, it was a given conclusion that the principles of clearing lymphedema fluid would apply in the parts of the body affected by such pressure.
An earlier patent by one of the inventors herein, U.S. Pat. No. 6,315,745, defined a system of cycling air filled cellules arranged in a horizontal plain and controlled by a computerized pump could intermittently control the physiologic metabolism in a dynamic fashion and thus prevent the formation of these subcutaneous lakes form forming.
As is well known in the art, lymphedema is a collection of fluids within the tissue, usually extremities, such as one or both of the arms, one or both of the legs, and which is caused from various etiological causes. Lymphedema can be a primary illness that is congenital. This can either result from aphasia of the lymphatic system, which may occur as a result of a complete lack of development of the same, or can be caused by hyperplasia of the lymphatic, such as an underdevelopment of the lymphatic system. Furthermore, lymphedema can be caused, and result from inflammatory diseases. These include mostly bacteriological infections. The non-infectious inflammatory causes are due to a variety of impairments, such as malignancies where the lymphatics can be blocked by tumor cells, or the lymph nodes can be blocked by tumor cells. In addition, it can result from the surgical removal of various lymph nodes, and the surgical interruption of the normal performance of the lymphatics.
Furthermore, such can come from radiation that causes sclerosis or scarring of the lymphatics. Furthermore, such can result from chronic venous diseases of long standing origin. In addition, lymphedema can come from severe local injury to a limb. Furthermore, it is usually the infectious element that accompanies such an injury that may result in the onset of lymphedema. Lymphedema can also originate from the blockage of lymphatics by various parasites. Finally, pathology in lymphatics can come from various systemic diseases including myxedema, renal disease, such as nephritis or nephrosis, with loss of protein materials, and can derive from various collagen diseases and fibrotic diseases. All of these diseases result in obstruction of the lymphatic flow and thus causes an accumulation of fluids in the effected limb or limbs. It is also known that cardiac failure can also cause the onset of this malady.
Until recent years, the lymphatic system's anatomy has only been demonstrated in its larger or more gross form. Millions of small lymphatic ducts have not been truly understood or demonstrated until the past several years, and only as a result of extensive research. The smaller lymphatics, which were cannulated under the magnification of the electron microscope, have been demonstrated as playing a role in the onset of this type of disease. Such had been predicted for a number of years, but it was not demonstrated until approximately two years ago. Now, the network of the lymphatic system is fairly well understood and known. The lymph system is actually inherent in all of the bodily organs, but the major part of the lymphatic system in the extremities is in the subcutaneous tissues. Such has been demonstrated.
The effects of lymphedema on the patient are well known. Patients generally are somewhat or significantly disabled according to the limb that is affected. Usually, with the onset of lymphedema, the patient either has one or two lower limbs that are very heavily affected, and manifest a heavy accumulation of such body fluids. As the disease progresses, it hampers the patient's ambulation and makes it very difficult for normal clothing to fit. Eventually, normal everyday activities become limited.
If lymphedema effects the upper extremity, the hand is markedly affected, and the mobility of the hand, fingers and thumb, etc., are eventually also affected. In addition, these people, subject to lymphedema, are very susceptible to various other serious infections. A very slight portal of entry, such as a cut, pin stick, hangnail, or the like, or anything that allows the entrance of bacteria into the lymphatic system becomes a very serious cellulitic process. This can reach proportions of fever and chills, and even require hospitalization, and if uncontrolled can even cause septic shock and death. The reason for this is that the lymph fluid is a perfect media for bacteria to grow in and there is an abundance of such fluid in those subcutaneous tissues.
Lymphedema is commonly seen in either the upper or lower extremities of the body as mentioned above. This can be either individually, or isolated in its location, depending upon where the lymph nodes have been removed, or it can manifest itself in a variety of these extremities, after its onset. Some of the cases of lymphedema are normally due to chronic venous disease. However, the largest number of such cases have been caused by secondary reactions to radiation and radical surgery where either all of the lymph nodes were removed from a groin area, the pelvis, or from an axilla. There was no real algorithm of treatment until the late 1980's.
Currently, literature has become more proliferative on the problems associated with lymphedema. Studies, even by the inventor herein, have focused more attention to lymphedema, and have led to an extrapolation of some hypothesis as to its etiology at the level of the microscopic lymphatics.
There are a variety of treatments that are currently available for lymphedema, and most of them, relate to some type of wrapping or compression of the effected area, in an effort to reduce the accumulation of the fluids. Many of the processes have included various types of wraps, or pumps, for achieving a dissemination of the localized fluids.
For example, the Reid sleeve is one such instrument that has been used for the treatment of lymphedema. See U.S. Pat. No. 5,916,183. It is a sleeve type compression device, almost in the nature of a cast, but in this instance, formed of more flexible type of nylon or related materials. Then, a series of straps can be tightened around the sleeve, at the situs of the accumulated fluids, and tightened by means of any type of fastener associated with such straps, in order to apply compression at the site of treatment. Thus, the essence of the Reid sleeve is simply to provide a massive amount of physical pressure by tightening of a sleeve about the infected area.
The use of such compression bandaging has provided some beneficial results to the patient, and has achieved limb reduction, enhanced skin tone, and softer skin texture, but, the use of such a bandage does have the potentially harmful effects of functioning like a tourniquet upon the effected area, and unless the amount of pressure applied is significantly controlled, can have further detrimental effects in the nature of reducing blood circulation and flowage, which can be very harmful to the patient, if not properly supervised. Most of these sleeve type of devices, available in the art, may be initially applied by the medical practitioner, in the office, but once the patient takes it home, he/she will either be advised or have a tendency to apply such sleeves themselves, which can afford no regulation over the amount of pressure applied by such a compression sleeve, once installed.
It has also been suggested, recently, that some type of air compressive means or strap may extend, at a slight width, along the internal length of the Reid or related sleeves, and be pumped up to provide additional tightness to the device encompassing the limb. But, once again, such applications offer little or no control over the amount of pressure applied, or the benefits or harm that may result from their usage, particularly when applied by the patient alone.
Various United States patents have previously issued relating to technology available for treatment of accumulation of body fluids, or for other treatments. For example, in the U.S. Pat. No. 4,029,087, entitled “Extremity Compression Device,” there is shown, as can be seen in its FIG. 1, a wrap that applies compressive pressures against the patient's limb, forming interconnecting annuluses, as noted, and which are inflated. Generally, this particular compression device is for application to patients that are bedridden, for some time, and with the added pressure it is believed that assistance to blood flow may be enhanced, to reduce swellings associated with edema in the extremities.
The compressive sleeve to Hasty, shown in U.S. Pat. No. 4,091,804, shows a form of sleeve that is applied to the patient's limb, and subjects the same to compressive pressure, as a result of the injecting of compressive air into the various chambers, as noted, to provide compressive pressures against the patient's limb.
The patent to Annis, U.S. Pat. No. 4,207,876, shows a compression device with ventilated sleeve. This device may be applied, as for example, to the leg of a patient, to apply compressive pressures, during treatment. This device includes various openings to provide ventilation to the limb, during the application of this compression device, when used for treatment.
The patent to Kapp, et al, U.S. Pat. No. 4,256,094, shows an arterial pressure control system. This device utilizes a fluid pump for inflating a cuff, which functions, apparently, to provide arterial pressure, not too unlike that of the manual tourniquet.
The patent to Dillon, U.S. Pat. No. 4,269,175, discloses an apparatus that promotes the circulation of blood. This particular device, when applied, as for example, to the leg, and fluid pressure is injected into the same, as can be seen in its FIG. 1, is designed to enhance or provide intermittent external pressure pulses to the leg, to enhance blood flow, to and from the heart.
The patent to Villanueva, U.S. Pat. No. 4,374,518, shows an electronic device for pneumomassage to reduce lymphedema.
This device includes the fabrication of an outer boot, that may fit, for example, to conform to the human foot and leg, and utilizes a compressor to provide for successive inflating and deflating of the boot, within a preselected cycle, in order to stimulate fluid flow.
The patent to Arkans, U.S. Pat. No. 4,396,010, shows a sequential compression device. This device, as with those as previously described, is a pressure generating device for applying compressive pressures from a compressor against the patient's limb, through the use of a flexible, prepressurizable sleeve that encloses the limb and apparently pulsates pressure to the sleeve, and on to the limb, to enhance fluid flow.
The patent to Mummert, U.S. Pat. No. 4,408,599, discloses another complex apparatus for pneumatically controlling a dynamic pressure wave device. This device includes a series of longitudinal chambers that are subject to pressure inflation or deflation, by a dynamic pressure generating device, which is highly controlled by means of electrically operated components.
The patent to Siemssen, et al, U.S. Pat. No. 5,179,941, shows a contractile sleeve element and compression sleeve made therefrom for the peristaltic treatment of extremities.
The patent to Cariapa, et al, U.S. Pat. No. 5,437,610 shows another complex device incorporating various compression units, and pump means, which functions as an extremity pump apparatus.
The patent to Tumey, et al, U.S. Pat. No. 5,443,440, shows another form of medical pumping apparatus, in this particular instance, for application to the foot, and which can be inflated, in order to apply pressure to the foot, during its treatment for various impairment.
The patent to Peeler, et al, U.S. Pat. No. 5,575,762, shows a gradient sequential compression system and method for reducing the occurrence of deep vane thrombosis. This is a complex apparatus, for treatment as a therapeutic medical device and method for improving the venous blood flow within the patient.
The patent to Cone, et al, U.S. Pat. No. 5,591,200, shows another method and apparatus for applying pressure to a body limb for treatment of edema. This device is similar to the Reid sleeve, as previously reviewed.
The patent to Tobler, et al, U.S. Pat. No. 5,626,556, discloses a hook and loop attachment on a compression sleeve. This particular device also is related to the Reid sleeve type of apparatus, as previously explained, and does provide for the application of air pressure, into the lateral annuluses, as shown; to provide an inflated pressure against the foot, as can be noted, for the treatment of the patient's leg, and perhaps other extremities.
U.S. Pat. No. 5,901,393, describes the use of alternating pressures of large irregular shaped cells but the cells are in a design wherein successive rolls are stacked upon each other very tightly, and such inflation of a cell cuts off air flow to adjoin cells and produces a “duck billing”. This patent was actually obtained to reduce “duck billing.”
Another U.S. Pat. No. 6,154,907, upon a pneumatic cushion having individually deformed cells, as individual cell that can be deformed by a pressure sensor. Electrical signals are delivered to a controller in case the cell is deformed. There's no mention of Alternating pressure for relieving pressure points upon the body, especially when lying in a prone position for some extended length of time.
U.S. Pat. No. 6,711,771, upon an alternating pad, is an alternating pressure pad but it is for use for bladders, and not cells.
U.S. Pat. No. 6,823,549, upon alternating pressure cushion with inflatable lumbar support provides a structure with much larger cells, and there is spacing between adjoining cells to reduce or eliminate the duck billing. Because of this configuration, there are pockets in the pad that are a void of cells where tissue would not see inflation and deflation, in order to remedy pressure points upon the body.
U.S. Pat. No. 7,278,179, is upon an inflatable decubitus mat with vent structures controlled by heat sensors. It does include alternating pressure technology but radically differ as the cells vent as heat from the body trips a heat sensor. As the cells deflate, supposedly the body will cool down. The heat sensor then closes an opening on the cell and a pump inflates the cell once again.
Published application No. US 2004/0111048, is upon a compression device for chronic venous inefficiency. This is a device with an inflatable boot.
Application No. US2007/0113351, is upon a patients support apparatus having an air cell grid and associated method. This is a pad with individual air cells. The disclosure does not discuss inflation and deflation of the pad.
Published US application No. 2007/0249977, is upon a pressurized medical device. This appears to be more of a leg device for venous ulcers.